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May 13, 2009 -- The FDA is warning General Mills about health claims on the Cheerios label, but General Mills says its science is strong.

In a warning letter sent to General Mills, the FDA notes Cheerios is "misbranded" in a way that makes the cereal sound like a drug to prevent, mitigate, and treat high cholesterol and heart disease.

As evidence, the FDA points to language on the Cheerios label that includes this statement: "Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is ... clinically proven to lower cholesterol. A clinical study showed that eating two 1.5 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol."

The FDA does allow a health claim linking soluble fiber from whole-grain oats with a lower risk of coronary heart disease, and also to include -- as part of that statement -- a note about lowering total and LDL cholesterol levels.

But according to the FDA, the Cheerios label inappropriately separates the heart disease and cholesterol claims.

The FDA also takes issue with a General Mills' web site mentioned on the Cheerios label that uses language that doesn't comply with approved health claims.

For instance, the approved health claim about heart disease is supposed to mention fiber, fruits, vegetables, and a low-fat diet -- not just whole-grain foods. And the FDA warned General Mills about another statement on that same web site that linked whole grains, as part of a low-fat diet, to reduced risk of stomach and colon cancers. That's not an approved health claim.

The FDA's warning letter, which is dated May 5, 2009, and is posted on the FDA's web site, gives General Mills 15 days to correct the problems.

In response, General Mills has posted a statement on its web site.

General Mills states that "Cheerios' soluble fiber health claim has been FDA-approved for 12 years, and Cheerios' 'lower your cholesterol 4% in 6 weeks' message has been featured on the box for more than two years. The science is not in question. The scientific body of evidence supporting the heart health claim was the basis for FDA's approval of the heart health claim, and the clinical study supporting Cheerios' cholesterol-lowering benefit is very strong."

General Mills states that the FDA "is interested in how the Cheerios cholesterol-lowering information is presented on the Cheerios package and web site." The company says it looks forward to discussing and resolving the matter with the FDA.